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Oct
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New SAHPRA Traceability Guideline Outlines Step-by-Step Implementation Roadmap
The South African Health Products Regulatory Authority (SAHPRA) has published its official Traceability Guideline, defining a structured roadmap for introducing unique product identification and unit-level serialisation across all health products in South Africa.
This marks a significant shift from batch-level identification to complete serialisation – ensuring every medicine pack can be traced through the entire supply chain, from manufacturer to patient.
Phase 1: Batch-Level Identification (2025 – 2029)
Data required:
GTIN (01), Expiry Date (17), and Batch/Lot Number (10).
Implementation deadlines:
- Imported products by October 2027
- Domestic products by October 2029
Phase 2: Unit-Level Serialisation (2027 – 2031)
This phase introduces the Serial Number (21), enabling fully traceable products and end-to-end visibility.
Implementation deadlines:
- Imported products – by October 2029
- Domestic products – by October 2031
Tertiary Packaging Requirements (Aggregation)
Trade Items: GS1 DataMatrix or GS1-128 barcode, exact timelines as above.
- Logistics Units: SSCC (00) required by October 2030.
Technical Standards & Data Requirements
- Barcodes must achieve print quality Grade C (≥ 1.5).
- Must comply with GS1 General Specifications, ISO/IEC 15416:2016, and ISO/IEC 15415:2011.
- Mandatory data elements: GTIN, Expiry Date, Batch/Lot, Serial Number, SSCC (for logistics).
Manufacturers must:
- Retain records of all unique identifiers for at least 5 years after product expiry.
- Ensure data is available upon request by SAHPRA.
By October 2026, companies are expected to complete:
- Internal traceability readiness assessments, and
- GS1 membership verification.
South Africa is following the global direction already adopted by the EU, MENA, and CIS regions, bringing local manufacturers closer to international compliance standards.
For pharmaceutical companies, this means:
- Planning early integration with GS1 standards,
- Upgrading packaging lines for serialisation and aggregation, and
- Preparing IT systems for regulatory reporting and data exchange.
With proven expertise across 12+ global markets, SoftGroup provides end-to-end serialisation and aggregation solutions – from hardware to regulatory reporting, ensuring complete alignment with SAHPRA’s upcoming requirements.
Our technology covers every compliance level — from production line serialisation to authority reporting, helping pharma companies in South Africa transition smoothly to unit-level traceability.